BEUDAMED
    9 results · 17ms · Sources: EU EUDAMED, US FDA

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    Pump Tube Set for MMS Libra and Solar Systems - Product Usage: Intended for use during water perfusion urodynamic procedures to study the function of the bladder and urethra during filling and voiding, by monitoring pressure and pressure changes.

    FDA Enforcement
    Class II ·Terminated·LABORIE MEDICAL TECHNOLOGIES, CANADA ULC·July 15, 2020

    Limbus AI Inc.

    Manufacturer
    🇨🇦 Canada·Kiwa Dare B.V.

    SmileSonica Inc.

    Manufacturer
    🇨🇦 Canada·Intertek Medical Notified Body AB

    Epocal Inc.

    Manufacturer
    🇨🇦 Canada·2 Importers·TÜV Rheinland LGA Products GmbH

    Dominion Biologicals Limited

    Manufacturer
    🇨🇦 Canada·TÜV Rheinland LGA Products GmbH

    HX 1804155-1

    Certificate
    IVDR QMS·Dominion Biologicals Limited·TÜV Rheinland LGA Products GmbH

    21M00123CRT01

    Certificate
    MDR QMS·Limbus AI Inc.·Kiwa Dare B.V.

    28620156455

    Certificate
    MDR QMS·SmileSonica Inc.·Intertek Medical Notified Body AB

    HX 2262557-1

    Certificate
    IVDR QMS·Epocal Inc.·TÜV Rheinland LGA Products GmbH